Articulating suturing device and method

ABSTRACT

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

The present application is a continuation application of and claimsbenefit of priority from application Ser No. 09/651,344 filed Aug. 29,2000 which is a divisional application of and claims the benefit ofpriority from application Ser No. 10/152,272 filed May 20, 2002 whichwas a continuation-in-part of and claims the benefit of priority fromapplication Ser. No. 09/651,344, filed Aug. 29, 2000, which is adivision of and claims the benefit of priority from application Ser. No.09/262,402, filed on Mar. 4, 1999, now U.S. Pat. No. 6,136,010. Thedisclosures of both application Ser. No. 09/651,344 and U.S. Pat. No.6,136,010 are hereby incorporated by reference.

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods for thesuturing of body lumens. More particularly, the present inventionrelates to techniques for percutaneous closure of arterial and venouspuncture sites, which are usually accessed through a tissue tract.

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established duringthe well-known Seldinger technique, as described, for example, inWilliam Grossman's “Cardiac Catheterization and Angioplasty,” 3.sup.rdEd., Lea and Febiger, Philadelphia, 1986, incorporated herein byreference. Vascular access is generally provided through an introducersheath, which is positioned to extend from outside the patient body intothe vascular lumen.

When vascular access is no longer required, the introducer sheath isremoved and bleeding at the puncture site stopped. One common approachfor providing hemostasis (the cessation of bleeding) is to applyexternal force near and upstream from the puncture site, typically bymanual or “digital” compression. This approach suffers from a number ofdisadvantages. It is time consuming, frequently requiring one-half houror more of compression before hemostasis is assured. Additionally, suchcompression techniques rely on clot formation, which can be delayeduntil anticoagulants used in vascular therapy procedures (such as forheart attacks, stent deployment, non-optical PTCA results, and the like)wear off. This can take two to four hours, thereby increasing the timerequired before completion of the compression technique. The compressionprocedure is further uncomfortable for the patient and frequentlyrequires analgesics to be tolerable. Moreover, the application ofexcessive pressure can at times totally occlude the underlying bloodvessel, resulting in ischemia and/or thrombosis. Following manualcompression, the patient typically remains recumbent from four to asmuch as twelve hours or more under close observation so as to assurecontinued hemostasis. During this time renewed bleeding may occur,resulting in blood loss through the tract, hematoma and/orpseudoaneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusion and/or surgicalintervention.

The incidence of complications from compression-induced hemostasisincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. It is clear that the compressiontechnique for arterial closure can be risky, and is expensive andonerous to the patient. Although the risk of complications can bereduced by using highly trained individuals, dedicating such personnelto this task is both expensive and inefficient. Nonetheless, as thenumber and efficacy of translumenally performed diagnostic andinterventional vascular procedures increases, the number of patientsrequiring effective hemostasis for a vascular puncture continues toincrease.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners or sealing bodies to stop bleeding haspreviously been proposed. Generally, these approaches rely on theplacement of a thrombogenic and bioabsorbable material, such ascollagen, at the superficial arterial wall over the puncture site. Whilepotentially effective, this approach suffers from a number of problems.It can be difficult to properly locate the interface of the overlyingtissue and the adventitial surface of the blood vessel. Locating thefastener too far from that interface can result in failure to providehemostasis, and subsequent hematoma and/or pseudo-aneurysm formation.Conversely, if the sealing body intrudes into the arterial lumen,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion. Also, thrombusformation on the surface of a sealing body protruding into the lumen cancause a stenosis, which can obstruct normal blood flow. Other possiblecomplications include infection, as well as adverse reaction to thecollagen or other implant.

A more effective approach for vascular closure has been proposed in U.S.Pat. Nos. 5,417,699, 5,613,974; and PCT published Patent Application No.PCT/US96/10271 filed on Jun. 12, 1996, the full disclosures of which areincorporated herein by reference. A suture-applying device is introducedthrough the tissue tract with a distal end of the device extendingthrough the vascular puncture. One or more needles in the device arethen used to draw suture through the blood vessel wall on opposite sidesof the puncture, and the suture is secured directly over the adventitialsurface of the blood vessel wall to provide highly reliable closure.

While a significant improvement over the use of manual pressure, clamps,and collagen plugs, certain design criteria have been found to beimportant to successful suturing to achieve vascular closure. Forexample, it is highly beneficial to properly direct the needles throughthe blood vessel wall at a significant distance from the puncture sothat the suture is well anchored in the tissue and can provide tightclosure. It is also highly beneficial to insure that the needledeployment takes place when the device is properly positioned relativeto the vessel wall. The ease of deployment and efficacy of the procedurecan further be enhanced by reducing the cross-section of that portion ofthe device, which is inserted into the tissue tract and/or the vesselitself, which may also allow closure of the vessel in a relatively shortamount of time without imposing excessive injury to the tissue tract orvessel.

For the above reasons, it would be desirable to provide improveddevices, systems, and methods for suturing vascular punctures. The newdevice should have the capability of delivering a pre-tied knot to anincision site. It would be particularly beneficial if these improveddevices provided some or all of the benefits while overcoming one ormore of the disadvantages discussed above.

DESCRIPTION OF THE BACKGROUND ART

U.S. Pat. Nos. 5,700,273, 5,836,956, and 5,846,253 describe a woundclosure apparatus and method in which needles are threaded with sutureinside a blood vessel. U.S. Pat. No. 5,496,332 describes a wound closureapparatus and method for its use, while U.S. Pat. No. 5,364,408describes an endoscopic suture system.

U.S. Pat. No. 5,374,275 describes a surgical suturing device and methodof use, while U.S. Pat. No. 5,417,699 describes a device and method forthe percutaneous suturing of a vascular puncture site. An instrument forclosing trocar puncture wounds is described in U.S. Pat. No. 5,470,338,and a related device is described in U.S. Pat. No. 5,527,321. U.S. Pat.No. 5,507,757 also describes a method of closing puncture wounds.

SUMMARY OF THE INVENTION

The present invention provides improved devices, systems, and methodsfor suturing of body lumens. The device often allows the suturing ofvascular puncture sites located at the distal end of a percutaneoustissue tract with greater ease, in less time, and with less patienttrauma than known systems. These improvements are generally providedthrough the use of shafts having smaller cross-sections than priorsuturing systems. In the exemplary embodiment, an elongate articulatedfoot near a distal end of a shaft is inserted through the penetrationand actuated so that the foot extends along the lumenal axis. The footcarries suture attachment cuffs, and can be drawn proximally up againstthe endothelial surface of the blood vessel. Needles are advanced fromthe shaft, through the vessel wall beyond the penetration, and intoengagement with the needle cuffs. The cross-section of the shaft withinthe tissue tract can be minimized by laterally deflecting the needlesbefore they leave the shaft, while tapered depressions within the footcan help guide the advancing needles into engagement with the cuffs. Thecuffs lockingly engage the needles so that the cuffs can be withdrawnproximally along the needle paths through the tissue tract so as to forma loop of suture across the puncture without having to thread theneedles directly with the suture inside the blood vessel. The sutureloop may be drawn distally from the shaft, proximally from within theblood vessel, or laterally down one of the needle paths, across thepuncture, and out the opposing path. Regardless, the articulating footmay be realigned with the shaft and withdrawn proximally through thetissue tract in a small profile configuration. The use of anarticulatable foot in combination with lateral deflection of the needlescan avoid dilation of the tissue tract, as was often necessary usingknown puncture closure systems.

In a first aspect, the invention provides a method for suturing apuncture through a vessel wall of a blood vessel. The puncture isdisposed within a tissue tract of a patient body, and the methodcomprises attaching a flexible filament to a first fitting. The firstfitting is inserted through the tissue tract and positioned adjacent thevessel wall, and a needle path is formed by advancing a first needlethrough the vessel wall. The needle is coupled with the first fitting,and the first needle, the first fitting, and at least a portion of thefilament are withdrawn through the vessel wall along the needle path.

First and second fittings will often be coupled to the flexiblefilament, and will generally be positioned so that the puncture isdisposed therebetween. The flexible filament will often comprise asuture extending between the first and second fittings, with eachfitting being drawn proximally by an associated needle so as to form thesuture loop. Alternatively, at least one of the needles may include adetachable tip and may advance a suture distally along the needle pathas the needle penetrates through the vessel wall. The flexible filamentcan again couple the first and second fittings, here allowing bothfittings to be withdrawn along a single needle path so that the sutureadvances down along the first needle path, laterally across thepuncture, and then out the other needle path.

Positioning of the fittings is generally effected by articulating anelongate foot within the blood vessel so that the foot extends along thevessel axis. A confirmation lumen may extend along a shaft supportingthe foot to ensure that the foot is positioned within the vessel priorto articulation. Once the foot is properly articulated, it can bewithdrawn to firmly engage the endothelial layer of the vessel. The footwill preferably include tapering depressions, which direct the advancingneedle toward the fitting, and the suture or other flexible filamentadjacent the fittings will often be releasably restrained within anarrow slot extending from the depression. The suture or other flexiblefilament and its associated slot will preferably be arranged to avoidentanglement of the advancing needle in the suture, and to ensure thatthe fitting and suture can be withdrawn proximally as the needle isretracted. An atraumatic, flexible monorail guidebody may extend fromthe shaft and/or the articulatable foot to facilitate alignment of thefoot with the vessel, and also to help provide hemostasis while the knotis tied. A wide variety of foot articulation mechanisms may be provided,with deployment preferably being effected when the foot is disposedentirely within the vessel and using an actuator and foot motion thatavoid dilation of the puncture.

In another aspect, the invention provides a method for suturing anopening in a tissue. The method comprises inserting a distal end of aprobe through the opening, the probe defining a probe axis. An elongatedfoot of the probe is articulated so that first and second ends of thefoot extend laterally with the opening aligned therebetween. A firstneedle path is formed from the probe, through the tissue, and to thefirst end of the foot. A second needle path is formed from the probe,through the tissue, and to the second end of the foot. Suture isadvanced along the first and second needle paths to position a sutureloop across the opening.

In another aspect, the invention provides a method for suturing a bloodvessel. The vessel has a vessel wall, and the method comprises advancinga shaft toward the vessel wall. The shaft has an axis and a plurality ofneedle guides. A foot is deployed adjacent the vessel wall so that thefoot extends laterally from the shaft. A plurality of needles isadvanced from the needle guides of the shaft to the foot to form needlepaths through the vessel wall. The needle guides deflect the needleslaterally so that a needle path width between the needles is greaterthan a cross-sectional dimension of the shaft. Suture is advanced alongthe needle paths to position at least one suture loop across thepuncture.

In yet another method of the present invention, a blood vessel issutured through a tissue tract of a patient body. The vessel has avessel wall, and the method comprises inserting a distal end of a probethrough the puncture and into the blood vessel. A first end of thesuture is advanced from the probe within the tissue tract, through thevessel wall, and into the vessel. The first end of the suture iswithdrawn from the vessel through the vessel wall, and through a bightof the suture to form a loop of suture across the puncture. The firstend of the suture and a second end of the suture adjacent the bight aretensioned to detach the bight from the probe and form a knot affixingthe loop of suture across the puncture. Advantageously, the bight ofsuture may be pre-tied before the probe is inserted into the tissuetract, the bight optionally being releasably attached to the probe.

In a device aspect, the invention provides a system for suturing a bloodvessel. The vessel has a vessel wall, and the system comprises a needlehaving a proximal end and a distal end suitable for forming a needlepath through the vessel wall. The needle has a recessed engagementsurface adjacent the distal end. The system further comprises a flexiblefilament and a fitting attached to the filament. The fitting has anopening and a tab extending into the opening, the tab securinglyengaging the engagement surface when the needle advances through thevessel wall and into the opening, so that the fitting and at least aportion of the filament can be withdrawn proximally along the needlepath by the needle.

In a further device aspect, the invention provides a system for suturinga puncture of a blood vessel within a tissue tract. The vessel has avessel wall and defines an axis, and the system comprises a shaft havinga proximal handle and a distal end suitable for insertion along thetissue tract and into the vessel through the puncture. A foot is mountednear the distal end of the shaft. The foot has plurality of needlereceptacles extendable laterally from the shaft. A flexible filamentextends between the receptacles of the foot. A plurality of needles isadvanceable distally and laterally from the shaft, through the vesselwall outside the puncture, and to the receptacles of the foot.

In yet another device aspect, the invention provides a system forsuturing a puncture of a blood vessel within a tissue tract. The vesselhas a vessel wall, and the system comprises a shaft having a proximalhandle and a distal end suitable for insertion along the tissue tractand into the vessel through the puncture. A foot is mounted near thedistal end of the shaft. The foot has a first needle receptacle and isarticulatable from a small profile configuration to a large profileconfiguration by actuation of the handle. A first fitting is removablymounted adjacent the first needle receptacle. A filament is coupled tothe first fitting. A first needle is advanceable from the shaft to thefirst needle receptacle on the articulated foot. The first fittingsecurely engages the first needle so that the secured first fitting andat least a portion of the filament can be drawn through the vessel wallby the first needle.

In a still further device aspect, the invention provides a probe forsuturing an opening in a tissue. The probe comprises a shaft having aproximal end and a distal end and defining an axis therebetween. Theshaft has a size and configuration suitable for insertion through theopening in the tissue. An elongate foot is movably mounted to the shaft.An actuator extends along the shaft distally to the foot. Movement ofthe actuator slides the foot axially and pivots the foot from a lowprofile configuration to a deployed configuration extending laterallyfrom the shaft. The foot supports a suture, and a needle is advanceablefrom the shaft, through the tissue, and to the deployed foot.

In another aspect, the invention provides a suturing device having afirst penetrator and a second penetrator for suturing an incision. Thefirst penetrator is configured to form a first penetration about aperiphery of the incision. The first penetrator also carries a pre-tiedknot disposed about a periphery of the first penetrator for delivery tothe incision. The second penetrator is configured to form a secondpenetration about the periphery of the incision. The second penetratoralso includes suture disposed thereon that is drawn by the firstpenetrator through the first penetration and through the pre-tied knotduring retraction of the first and second penetrators from around theperiphery of the incision. The first penetrator draws the suture throughthe first penetration via a connection between the first penetrator andthe suture. Moreover, as the first penetrator draws the suture, thesuture delivers the pre-tied knot to the incision for closure of theincision.

In another aspect, the invention provides a suturing device for suturingan incision formed in an artery. The suturing device includes a firstpenetrator, a second penetrator and a receiver. The first penetrator,which forms a first penetration about a periphery of the incision,includes a pre-tied knot disposed about the first penetrator. The secondpenetrator, which forms a second penetration about the periphery of theincision, has suture disposed thereon, which retracts through the firstpenetration. The suture retracts through the first penetration into thepre-tied knot during retraction of both the first penetrator and thesecond penetrator from around the periphery of the incision. Inaddition, during retraction, the suture delivers the pre-tied knot tothe incision for suturing of the incision. The suturing device alsoincludes a receiver for receiving both the first penetrator and thesecond penetrator upon penetration formation. The receiver connects thesuture to both the first penetrator and the second penetrator and allowsretraction of the suture through the first penetration as the firstpenetrator and the second penetrator retract.

In another aspect, the invention provides a suturing device for suturingan opening of an artery of a patient during a surgical procedure. Thesuturing device includes a first penetrator, a second penetrator and afoot. The first penetrator is disposed about a periphery of the suturingdevice and the second penetrator is located opposite the firstpenetrator on the suturing device. The first penetrator includes apre-tied knot configured to receive suture releasably engaged with thesecond penetrator during suturing of the opening of the artery. Thefoot, which is movably coupled to the suturing device distal to thefirst penetrator and the second penetrator, includes a first cuff and asecond cuff. The first cuff and the second cuff, which couple to oneanother via a link, receive the first penetrator and a detachable end ofthe second penetrator respectively. The first and second penetratorspenetrate the artery at a proximal end of the suturing device and couplewith the first cuff and the second cuff upon penetration of the artery.The first and second penetrators couple with the first cuff and secondcuff such that during retraction of the first penetrator and the secondpenetrator from the artery, the suture delivers the pre-tied knot to theincision for closure of the incision.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of a percutaneous blood vessel closure deviceaccording the principles of the present invention.

FIG. 2 illustrates the vessel closure device of FIG. 1 in which anelongate foot is shown in a deployed position.

FIGS. 2A-C illustrate actuation of a foot and advancement of needlesfrom a shaft to the articulated foot in a probe similar to the probe ofFIG. 1.

FIG. 3A is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a parked position prior to deployment.

FIG. 3B is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a deployed position.

FIGS. 4 and 4A are perspective views illustrating a suture attachmentcuff and an associated barbed needle for use in the vessel closuredevice of FIG. 1.

FIG. 5 is a cross-sectional view showing the barbed needles securinglyengaging the suture cuffs of the deployed foot.

FIGS. 6A-C illustrate one embodiment of a deployable foot, in which thefoot slides and pivots when drawn proximally by a tension member.

FIG. 7 illustrates the suture cuff positioned within a needlereceptacle, and also shows how the suture is releasably secured within aslot extending radially from the needle receptacle.

FIGS. 8A-C illustrate an alternative foot articulation mechanism inwhich lateral slots on the foot receive pins from the shaft to allow thefoot to pivot and slide axially.

FIGS. 9A and B illustrate a still further alternative foot actuationmechanism in which the foot slides axially within a slot.

FIGS. 9C and D illustrate a further foot actuation mechanism in whichrelative movement between the sides of a two-part shaft actuates thefoot.

FIGS. 10A-D illustrate alternative structures and techniques foravoiding entanglement of the needle with the suture.

FIGS. 11A-E illustrate an alternative closure system and method for itsuse in which a first needle advances the suture to the foot, while asecond needle engages and withdraws both the first and second suturecuffs, a flexible filament connecting the suture cuffs, and at least aportion of the suture from within the blood vessel so as to complete apre-tied knot.

FIGS. 12A and B illustrate an alternative probe having two pairs ofneedles and a foot with four needle receptacles so as to form two loopsof suture across a puncture of a blood vessel.

FIGS. 13A-G illustrate a method for use of a suture system so as toeffect hemostasis of a blood vessel puncture through a tissue tract.

FIGS. 14A and 14B are enlarged partial side views of a suturing devicein accordance with one embodiment of the present invention.

FIGS. 15A through 15F are enlarged cross-sectional views of theembodiment of the suturing device of FIGS. 14A and 14B.

FIGS. 16A and 16B are schematic views of a suture bight having apre-tied knot in accordance with one embodiment of the presentinvention.

FIGS. 17A through 17D show enlarged partial cross-sectional views of anembodiment of the suturing device in accordance with the invention, inwhich one embodiment of a penetrator tip and cuff engagement, penetratortip disengagement, and cuff ejection sequence is illustrated.

FIG. 18A is an enlarged partial cross-sectional view of an embodiment ofa foot in accordance with the present invention, showing the linkrouting through the suture bearing surfaces of the foot.

FIG. 18B is an enlarged partial cross-sectional view of an embodiment ofa device in accordance with the present invention, showing the linkrouting through a suture- bearing surface located distal to the foot.

FIGS. 19A and 19B are enlarged partial cross-sectional views of anembodiment of a foot in accordance with the present invention, showingan alternate penetrator tip and cuff engagement, penetrator tipdisengagement, and cuff ejection sequence.

FIGS. 20A through 20C are enlarged partial cross-sectional views of anembodiment of a foot in accordance with the present invention, showingan alternate penetrator tip and cuff engagement, penetrator tipdisengagement, and cuff ejection sequence.

FIG. 21 is an enlarged perspective view of an embodiment of the pre-tiedknot in accordance with the present invention.

FIGS. 22A through 22C show an alternate embodiment of a foot inaccordance with the invention.

FIGS. 23A through 23C show another alternate embodiment of a foot inaccordance with the invention.

FIGS. 24A and 24B are perspective views of an alternative embodiment ofa penetrator tip in accordance with the invention.

FIGS. 25A through 25C are schematic views of an alternate embodiment ofa vessel closure device in accordance with the present invention.

FIGS. 26A through 26D are schematic views of alternate embodiments of avessel closure device in accordance with the invention.

FIG. 27 shows a schematic view of one embodiment of a link and cuffassembly in accordance with the invention.

DETAILED DESCRIPTION

A suturing device, which delivers a pre-tied knot to an incision, isdisclosed. As an overview, a suturing device in accordance with thepresent invention includes a first penetrator having a pre-tied knotdisposed thereabout and a second penetrator having suture disposedthereon. During operation of the suturing device, the first penetratorand the second penetrator penetrate the tissue about a periphery of anincision in a body lumen. Upon penetration, a penetrator tip releasablyengaged with the first penetrator couples with a foot of the suturingdevice. As the first and second penetrators retract from the body lumen,the penetrator tip and the suture coupled with the penetrator tipretract through a penetration formed in the body lumen by the firstpenetrator. As will be discussed in greater detail with reference to theaccompanying Figures, as the suture retracts, the pre-tied knot receivesthe suture, forming a knot for suturing the incision in the body lumen.

Referring now to FIG. 1, a vessel closure device 10 generally has ashaft 12 having a proximal end 14 and a distal end 16. A proximalhousing 18 supports a needle actuation handle 20. A flexible, atraumaticmonorail guidebody 22 extends distally of distal end 16 of shaft 12.

As can be seen with reference to FIG. 2, a foot 24 is articulatablymounted near the distal end of shaft 12. Foot 24 moves between a lowprofile configuration, in which the foot is substantially aligned alongan axis of shaft 12 (as illustrated in FIG. 1), to a deployed position,in which the foot extends laterally from the shaft, upon actuation of afoot actuation handle 26 disposed on proximal housing 18.

FIGS. 2A through C illustrate the structure and actuation of foot 24 ofa preferred probe 10′ having a modified proximal housing, and also showhow needles 38 can be advanced distally from shaft 12 to the foot bydepressing needle actuation handle 20.

Actuation of foot 24 is illustrated more clearly in FIGS. 3A and B. Inthe parked position illustrated in FIG. 3A, foot 24 extendssubstantially along axis 28 of shaft 12. Note that the axis of the shaftneed not be straight, as the shaft may curve somewhat, particularlyadjacent the foot. In the exemplary embodiment, foot 24 is substantiallydisposed within a foot receptacle 30 of shaft 12 so as to minimize thecross-section of the device adjacent the foot prior to deployment.Advantageously, prior to deployment of the foot, device 10 can have across-section adjacent foot 24 of about 7 Fr or less, ideally having across-section of about 6 Fr or less for the entire device distally ofthe proximal end 14 of shaft 12.

Actuation of foot handle 26 slides a foot actuation wire 32 proximally,pulling foot 24 from a parked position to the deployed positionillustrated in FIG. 3B. Once deployed, a first end 24 a and a second end24 b of foot 24 extend laterally from the shaft. Suture 34 herecomprises a continuous filament with ends disposed in needle receptaclesadjacent each end of the foot. An intermediate portion of suture 34 mayextend proximally along a suture lumen of shaft 12 to and/or beyondproximal housing 18. Alternatively, in preferred probe 10′, the lengthof suture between the ends may extend distally within flexible guidebody22, preferably in a dedicated lumen (separate from the monorailguidewire lumen). In still further alternatives described below, a shortlength of suture or some other flexible filament may extendsubstantially directly between the needle receptacles.

Shaft 12 also includes a foot position verification lumen that extendsdistally from a position verification port 36 to a position indicator athousing 18. When the foot is properly positioned within the bloodvessel, blood pressure will cause blood to flow proximally through theindicator lumen to the indicator. The indicator may optionally comprisea blood exit port, a clear receptacle in which blood is visible, or thelike. In the exemplary embodiment, the indicator of handle 18 comprisesa length of clear tubing extending from housing 18 (not shown) in whichthe blood is clearly visible. It should be understood that a widevariety of alternative position verifications sensors might be used,including electrical pressure sensors, electrolytic fluid detectors, orthe like.

The structures used in positioning a loop of suture across the puncturecan be understood with reference to FIGS. 4, 4A, and 5. In generalterms, needles 38 extend from shaft 12 into secured engagement withfittings 40 attached to sutures 34. More specifically, needles 38include a barbed end 42 defining a recessed engagement surface 44.Fittings 40 are roughly cylindrical structures having an axial channel46 that receives barbed end 44 of needle 38 therein. A first slot is cutin fitting 44 so as to define at least one tab 48. Tabs 48 can beresiliently biased inward into channel 46. As needle 38 advances intofitting 40, barbed end 42 resiliently displaces tab 48 clear of channel46 so as to allow the barbed end to pass axially into the fitting. Oncebarbed end 42 is disposed axially beyond tab 48, the tab resilientlyflexes back into the channel, capturing needle 38 by engagement betweenthe tab and recessed surface 44. As each tab can hold the fitting inplace on the needle, the use of more than one tab increases thereliability of the system. Ideally, three tabs are provided, asillustrated in FIG. 4A.

To facilitate attachment of fitting 40 to suture 34, a second slot cutin the tubular fitting structure defines a suture attachment collar 50.Optionally, collar 50 maybe crimped about suture 34 to mechanicallyaffix the suture to fitting 40. In addition and/or instead of mechanicalcrimping, suture 34 may be bonded to fitting 40 using an adhesive, heat,fasteners, knots, or the like.

Fitting 40 is quite small in size, and is generally configured tofacilitate withdrawing the fitting (and the attached suture) along withneedle 38 axially through the vessel wall along the needle path. Needle38 will generally have a cross-sectional width of between about 0.010inches and 0.020 inches. Barb 42 will extend laterally so as to definean engagement surface 44 having a protruding length of between about0.002 inches and 0.005 inches. Fitting 40 will preferably have across-sectional size roughly corresponding to or only slightly largerthan needle 38. Fitting 40 will typically have an outer lateral width ofbetween about 0.014 inches and 0.025 inches, and an axial length ofbetween about 0.035 inches and 0.050 inches. Channel 46 will be sized toreceive at least a portion of needle 38, and will generally have a widthof between about 0.010 inches and 0.020 inches. Suture 34 willpreferably extend axially opposite the open end of channel 46 so as tominimize drag when the suture is drawn proximally along the needle path.In the exemplary embodiment, needle 38 has a diameter of about 0.020inches, while the fitting comprises a tube having an outer diameter ofabout 0.020 inches, an inner diameter of about 0.016 inches, and anoverall length of about 0.047 inches. The fitting will typicallycomprise a resilient material, preferably comprising a metal, and in theexemplary embodiment, comprising stainless steel.

Needles 38 typically have a length of between about 5.0 inches and 6.0inches, and will preferably be sufficiently stiff to be advanced incompression through the vessel wall (and adjacent tissues) for up to 0.5inches when supported in cantilever. Nonetheless, the needles willideally be flexible enough to be laterally deflected within shaft 12, ascan be understood with reference to FIG. 5. Needles 38 generallycomprise a high strength metal, ideally comprising stainless steel.Fittings 40 will also preferably comprise a flexible material to allowtab 48 to flex out of the way of barbed end 42, and to resilientlyrebound and engage recessed surface 44. In the exemplary embodiment,barbed end 42 has a diameter of about 0.015 inches, with the diameter ofthe needle decreasing to about 0.008 inches proximally of the barb so asto define the recessed engagement surface.

As was generally described above, foot 24 includes needle receptacles 52adjacent the ends of the foot. A fitting 40 (with an associated end ofsuture 34) is disposed within each needle receptacle, and a surface ofthe receptacle tapers proximally and outwardly so as to guide theadvancing needles 38 into engagement with fittings 40 when foot 24 is inthe deployed position. As fittings 40 (and associated portions of suture34) are releasably supported in the foot, needles 38 can be withdrawnproximally so as to draw the fittings and suture ends from the footproximally into (and optionally through) shaft 12. The needlereceptacles of the exemplary embodiment taper outward at an anglebetween 20 and 35 degrees from the centerline of fitting 40, and thefitting is held in a recess having a diameter of about 0.0230 inches anda length of about 0.042 inches. A lateral opening or window through theside of foot to the fitting recess may be provided to facilitate needleand/or cuff positioning during assembly of the probe, and a protrudingcollar near the proximal end of the fitting recess may help keep thefitting in position.

FIG. 5 also illustrates the lateral deflection of needles 38 by needleguides 54 of shaft 12. This lateral deflection of the needles allows theuse of a small diameter shaft, while still encompassing sufficienttissue within the suture loop on opposite sides of the puncture so as toeffect hemostasis when the suture looped is tightened and secured. Inthe exemplary embodiment, shaft 12 comprises an outer casing of abiocompatible material such as stainless steel, carbon fiber, nylon,another suitable polymer, or the like. Needle guides 54 may be definedat least in part as lumens formed within the casing of a polymericmaterial such as nylon or the like. In some embodiments, shaft 12 maycomprise a carbon fiber filled nylon, or carbon fiber filled with analternative material.

One example of a suitable structure and articulation motion for foot 24is illustrated in FIGS. 6A and B. Foot actuation wire 32 (see FIG. 3A)rides in a lumen of shaft 12, and draws foot 24 from a parked position(shown in FIG. 6A) to a deployed position (shown in FIG. 6B) through acombination of sliding and pivoting of the foot. The foot remainssupported throughout its range of motion by arms disposed laterally oneither side of the foot, the arms defining (at least in part) footreceptacle 30. Once foot 24 is deployed, needle receptacles 52 and/orthe fittings disposed therein will preferably define a lateral suturingwidth 56 in a range from about 0.260 inches to about 0.300 inches. Foot24 may be machined or cast from a polymer or metal, but will preferablycomprise a polymer such as carbon fiber filled nylon. In some cases,foot 24 may be molded as two separate halves that can subsequently beaffixed together. Needles 38 advance from the fixed needle guides 54,and are laterally directed into fittings 40 by receptacles 52, asillustrated in FIG. 6C. In general, a shape memory alloy such asNitinol.™. in its superelastic regime provides a particularlyadvantageous actuator wire for manipulating foot 24.

Referring now to FIG. 7, fittings 40 and suture 34 will be withdrawnproximally by the needles from needle receptacles 52. To releasablysupport fittings 40 and suture 34 and avoid entanglement of the suturein the needles, suture 34 is fittingly received within a slot 58 thatextends laterally from needle receptacles 52. As the needles pull thefitting axially from needle receptacles 52, suture 34 is pulled fromslot 58 and free from foot 24. Bending of the suture proximally withinthe suture slot can also locally increase the suture width, so that theinteraction between the bent suture and the slot can help hold thefitting in the recess.

A wide variety of foot actuation mechanisms might be used within thescope of the present invention. A first alternative foot actuationarrangement is illustrated in FIGS. 8A-C. In this embodiment, a shaft 12i has pins 60 which ride in associated slots 62 of a foot 24 i. Proximalmotion of an actuation wire causes foot 24 i to move axially androtationally, with pins 60 sliding along slot 62, and the foot pivotingabout the pins. In this embodiment, guidebody 22 extends directly fromthe foot, as illustrated in FIG. 8C.

A still further alternative foot actuation mechanism is illustrated inFIGS. 9A and B. In this embodiment, slidable foot 24ii is slidinglyreceived within a receptacle 30 of shaft 12 ii. Sliding of the foot 24ii from the parked position of FIG. 9A to the deployed position of FIG.9B places the needle receptacles 52 in the paths of needles from theshaft 12 ii without pivoting of the foot. Guidebody 22 (see FIG. 1) willextend here from a distal end of shaft 12 ii at a fixed angle from theshaft. Optionally, insertion through the tissue tract may be facilitatedby including an additional bend in the shaft axis adjacent the guidebodyon many embodiments.

Yet another foot actuation mechanism can be understood with reference toFIGS. 9C and D. Shaft 12 iii is formed in two parts, which slide axiallyrelative to each other when foot actuation lever 26 iii moves, using anoffset crank arrangement. A similar offset crank supports foot 24 iii,so that the sliding shaft parts cause the foot to pivot as shown.

A variety of features may be included in the articulatable foot, theneedle receptacle, and/or the needle to avoid tangling of the needle inthe suture as the needle is directed to the fitting. As illustrated inFIG. 10A, a moveable flap 64 may extend over slot 58 so that theadvancing needle slides along the flap toward the fitting, rather thanentering the slot and engaging the suture directly. Flap 64 may beaffixed along one side of the slot, with the other side of the flapflexing into the receptacle to release the suture from slot 58 when thefitting and suture are withdrawn by the needle.

An alternative mechanism for avoiding entanglement of the needle withthe suture is illustrated in FIG. 10B. In this embodiment, needlereceptacles 52 i have tangential slots 58 i which extends substantiallytangentially to the surface of the receptacle. As a result of thistangential arrangement, a needle entering the receptacle 52 i will bedirected toward the fitting contained therein, but will generally not beable to enter and advance within the tangential slot 58 i so as tobecome entangled with the suture. As illustrated in this embodiment, theslots may optionally extend laterally through the foot so that the loopof suture can be pulled from one side of the shaft without interference.

A still further alternative mechanism for avoiding entanglement betweenthe suture and the needle is illustrated in FIGS. 10C and D. Two-partneedle 38 i includes an outer sheath 66 and an inner core 68. The partsof these needles initially advance together into the receptacles withthe needle core 68 withdrawn so that the needle presents a smoothtapered tip (the combined tip preferably being larger in diameter thanthe slot containing the suture) as illustrated in FIG. 10C. Oncetwo-part needle 38 i is fully positioned within the needle receptacle,needle core 68 may extend axially to expose barbed tip 42 and recessedengagement surface 44 and to secure the needle to the fitting within theneedle receptacle. In the exemplary embodiment of FIGS. 4 and 5, barbedtip 42 is formed integrally with the rest of the needle structure, butthe tip has a larger cross-section than radial slot 58 containing thesuture 34. As a result, the barbed tip is unable to enter the slot,thereby avoiding entanglement between the needle and suture.

An alternative vessel closure probe 70 will be explained with referenceto FIGS. 11A through 11E. This embodiment include an articulatable foot24 having a pair of needle receptacles 52, as described above. Althougheach needle receptacle 52 contains a fitting 40 for coupling a flexiblefilament to a tip of an associated needle, the filament in this casecomprises a temporary connecting filament 74, as shown schematically inphantom in FIG. 11A, spanning directly between the needle receptacles.Rather than pulling the two ends of an extended loop through the needlepaths and proximally out the tissue tract for tying, closure system 70advances a single end of the suture distally along one needle path,across the puncture, and then proximally along the other needle path. Toprovide this interaction, at least one needle include means forattaching a suture 34 to connecting filament 74, herein the form of adetachable coupling structure carried on the at least one needle. Thisstructure facilitates the use of a pre-tied knot.

Referring now to FIGS. 11A and B, the distal end of probe 70 advancesdistally through skin S and into a tissue T of the patient while theprobe is in the small profile configuration with foot 24 aligned alongthe axis of the probe. Here, however, an end 76 of suture 34 is affixedto a detachable needle tip 78 of a hollow needle 38′. Detachable tip 78comprises a fitting having an opening receiving an end of suture similarto fitting 40, attached to a barbed needle end (similar to that ofneedle 38). Suture 34 may extend proximally within hollow needle 38where the needle has an open channel along its length, may exit thehollow needle just proximally of detachable tip 78, or may be disposedalongside a solid needle. Needle 38 (opposite hollow needle 38′) has afixed barbed tip, as described above, and a bight of suture 80 isreleasably attached to the probe shaft encircling the opening of needleguide 54 of the fixed tip needle. The bight of suture may be releasablydisposed within a slot of the probe, may be temporarily held in place bya weak adhesive or coating, or the like. A second end 82 of suture 34extends proximally along the shaft of the probe, the second end of thesuture optionally also being releasably held along the shaft.

Bight 80 will define a knot when first end suture passes therethrough,as can be understood with reference to FIGS. 11Ai and 11Aii. Bight 80will often include more than one loop, and may be pre-arranged so as todefine a square knot (using the layout schematically illustrated in FIG.11Ai), a clinch knot (FIG. 11Aii), or a variety of known or new surgicalknots.

Probe 70 advances along tissue tract TT to puncture P in blood vessel V.

Once foot 24 is disposed within a blood vessel V, a pull wire moves thefoot proximally and pivots the foot laterally so that the foot extendsalong an axis A of the vessel, as illustrated in FIG. 11B. The foot canthen be pulled proximally against an inner surface of the vessel wall Wto ensure that the needle receptacles 52 are properly positioned.

As can be understood with reference to FIGS. 11C and D, hollow needle38′ and needle 38 advance to engage fittings 40 within receptacles 52.Hollow needle 38′ draws first end 76 of suture 34 distally throughvessel wall W, and detachable tip 78 is secured into an associatedfitting 40 using the barb and tab interaction described above. Asconnecting filament 74 extends between fittings 40, and as detachabletip 78 can pull free of hollow needle 38′ when the needles arewithdrawn, this effectively couples needle 38 to first end 76 of suture34. The detachable tip riding partially within the hollow needle (orvice versa) so that the assembly remains together under compression.Hence, needle 38 can pull the suture distally along the needle pathformed by hollow needle 38′, across the puncture P, and proximally alongthe needle path formed by needle 38, as illustrated in FIG. 11D.

FIGS. 11D and E show that the knot can be completed by pulling needle38, connecting filament 74, and first end 76 of suture 34 (together withthe fittings 40 and detachable needle tip 78) proximally through bight80. Second end 82 of suture 34 can be pulled to free bight 80, and theends of the suture can be tightened and the probe removed to providepermanent hemostasis.

It will be recognized that removal of probe 70 can be facilitated bycoupling first end 76 to bight 80 over an outer surface of the probe,and by arranging suture 34 and hollow needle 38′ so that the suture canpull free of the needle when detachable tip 78 is released, for example,by having the suture exit the needle proximally of the tip through achannel that extends to the tip so that the needle does not encircle thesuture. By including such provisions, after foot 24 is returned to thenarrow configuration, the probe can be pulled proximally from the tissuetract leaving the pre-tied knot in place.

Alternative arrangements (using the detachable needle ends of probe 70)are possible to provide the benefit of a pre-tied knot and the like forclosure of a vessel puncture. For example, a probe having a pair ofneedles in which each needle included a detachable tip might be used topull first end 76 through a bight, so that the bight need not encirclethe needle path of one of the needles.

In some cases, particularly for closure of large punctures, it may beadvantageous to provide multiple suture loops across the puncture,either in parallel, in an “X” pattern, or the like. As illustrated inFIGS. 12A and B, the present invention encompasses the use of more thantwo needles and associated receptacles, fittings, sutures, and the like.Multiple loop systems may have four, six, eight, or more needles, or mayeven have odd numbers of needles and fittings, particularly where one ormore fittings have a plurality of suture ends extending therefrom. Thisallows a wide variety of stitching patterns to be provided by suchmultiple loop probes.

The method of use of the probes of FIGS. 1-7 can be understood withreference to FIGS. 13A-G. After accessing a blood vessel V (often usingthe Seldinger technique), a guidewire GW is left extending into skin Sand down through tissue T along tissue tract TT. Guidewire GW entersvessel V through a puncture P in vessel wall W, and extends along thevessel throughout many endovascular procedures. As illustrated in FIG.13A, distal guidebody 22 is advanced over the guidewire GW in a monorailfashion, so that the guidewire helps to direct the probe along thetissue tract TT and into the vessel through puncture P. FIG. 13B showsthat when sensor 36 is disposed within the vessel, blood can flow fromthe sensor port and through a lumen in shaft 12 to the proximal handleto notify the operator that foot 24 has been advanced far enough fordeployment.

Deployment of the foot is effected by actuation of the foot deploymenthandle, as described and illustrated above with reference to FIGS. 2 and2B. As described above, guidebody 22 helps to align the probe with theaxis of vessel V. Guidebody 22 may be set at an angle and/or offsetrelative to shaft 12 as appropriate to aid in alignment with aparticular vessel access technique. As shown in FIG. 13C, the deployedfoot 24 extends laterally from the shaft, so that foot 24 adjacentreceptacles 52 can be drawn up against vessel wall W by gently pullingshaft 12. Hence, the foot helps to accurately position the needle guides54 at a distance from the vessel wall.

Referring now to FIG. 13D, flexible needles 38 are deflected laterallyby needle guides 54 toward receptacles 52 of the deployed foot. As aresult, the needles advance in cantilever both distally and laterallywhen needle actuation handle 20 is pressed (see FIG. 2C), and thetapering surfaces of receptacles 52 help to push the needles back intoalignment with the fittings so as to overcome any unintended deflectionof the needles by tissue T or vessel wall W. This ensures that needles38 securingly engage fittings 40 within receptacles 52, thereby couplingthe ends of suture 34 to the needles. While suture 34 is hereillustrated running along the side of shaft 12 outside foot receptacle30 to a lumen within guidebody 22, it should be understood that thesuture loop might instead extend proximally in a lumen of shaft 12,might be routed through the foot and/or foot receptacle, and/or might bestored in a spool adjacent foot 24. Regardless, suture 34 should able topull free of the probe between its ends to form a continuous loop acrosspuncture P.

Referring now to FIGS. 13E and F, fittings 40 and the ends of suture 34are drawn proximally through the vessel wall W along the needle pathsformed by needles 38. Optionally, the needles may be withdrawnproximally out of the tissue tract and clear of shaft 12, or they mayremain coupled to the shaft within needle guides 54. The foot actuatoris moved to store foot 24 along shaft 12, and the shaft can then bepulled proximally from the tissue tract. Guidebody 22, which maycomprise a soft, compliant polymer, may temporarily extend at leastpartially into tissue tract TT and through puncture P to help reduce theloss of blood until the loop is secured.

Now referring to FIG. 13G, once shaft 12 has been withdrawn sufficientlyto expose needle guides 54, the ends of the suture loop can be graspedby the operator. Tying of a knot in suture 34 can then proceed in aconventional manner. The use of a clinch knot may facilitate gradualtightening of the knot while removing guidebody 22, although a widevariety of knot and knot advancing techniques might be used.

FIGS. 14A and 14B show an embodiment of a vessel closure device 100.This embodiment includes an articulatable foot 114 (FIG. 14B) having apair of penetrator receptacles (described below). Although eachpenetrator receptacle contains a fitting (or cuff) for coupling aflexible filament to a tip of an associated penetrator, the filament inthis case may be a short length of suture such as a link 112 spanningdirectly between the penetrator receptacles. Rather than pulling the twoends of an extended loop through the needle paths and proximally out thetissue tract for tying, closure system 100 advances a single end of thesuture distally along one needle path, across the puncture, and thenproximally along the other needle path. To provide this interaction, atleast one needle includes means for attaching suture 102 to the link112, here in the form of a detachable coupling structure carried on theat least one needle. This structure facilitates the use of a pre-tiedknot.

FIG. 15A shows a side, cross-sectional view of the device 100 in aposition prior to deployment of the foot 114. The device 100 has beenadvanced through the incision 105 in the arterial wall W. For ease ofdescription, reference numeral 122 indicates the anterior side of thedevice, and reference numeral 124 denotes the posterior side of thedevice. Device 100 has a rigid shaft 118 that has channels definedtherein to carry the elongate bodies or penetrators 106 and 106′.Penetrator 106′ may also be referred to as the anterior penetrator, andpenetrator 106 may be referred to as the posterior penetrator. Forpurposed of description and not limitation, the anterior penetrator 106′carries the pre-tied knot 104, and posterior penetrator 106 carries thedetachable coupling structure or penetrator tip 108. Anterior penetrator106′ defines a penetrator tip 108′ at its distal end.

The articulatable foot 114 includes anterior and posterior penetratorreceptacles 116′ and 116, respectively. These receptacles are alsoreferred to as cuff pockets. Cuffs 110 are shown positioned in cuffpockets 116′ and 116. A link 112 extends between the cuffs 110.

FIG. 15B shows the foot 114 deployed so as to position the cuff pockets116 to receive the first and second penetrators 106′ and 106. As shownin FIG. 15B, the anterior penetrator 106′ has the pre-tied knot 104disposed about a proximal portion of its length. Alternatively, thepre-tied knot 104 may be disposed about the periphery of a knot tube,through which the anterior penetrator 106′ may pass (as described infurther detail below).

FIG. 15B illustrates the suturing device 100 deployed within a lumen 107in accordance with an embodiment of the present invention. As may beseen with reference to the Figure, the suturing device 100 includes anelongate body 106′ having a penetrator tip 108′. The elongate bodies 106and 106′ deploy to form penetrations 109 and 109′ within the vessel wallW. The configuration of the penetrator tip 308 allows penetration of thevessel wall W immediately surrounding the incision 105 to form thepenetration 309. As such, the penetration of the penetrator tip 108through the tissue wall W allows for passage of the elongate body 106through the tissue and into the lumen 107. The elongate body 106 holdsthe suture 102 as the elongate body 106 passes through the tissue wall Wimmediately adjacent the incision 105 and into the foot 114.

As may be seen with reference to FIG. 15B, in this embodiment, the foot114 has a single unit design where the cuffs 110 and 110′ are disposedon opposite sides of the suturing device 100 and the foot 114. Thisorientation allows balance of forces during the deployment of theelongate bodies 106 and 106′, thereby allowing precise suturing andminimizing the possibility of incorrectly suturing the incision 105.Also, as may be seen with reference to the Figure, the suturing device100 delivers the suture longitudinally relative to the lumen 107,thereby minimizing arterial diameter constriction. Likewise, in thisembodiment, the foot 114 is positioned at an angle “Q” relative to theshaft 118 of the suturing device 100. Preferably, the angle “Q” is in arange between about 20 degrees and about 60 degrees and more preferablyis about 40 degrees. The angle “Q” approximates the puncture anglecommonly used to access the femoral artery. The angle Q and the rigidcharacter of the shaft 118 serve to provide accurate, virtuallysimultaneous “cuff capture” by both the anterior and posteriorpenetrators. Moreover, since the device 100 is preferably used withoutan introducer sheath, the rigid nature of the shaft 118 provides thecontrol of the travel of penetrators as they move distally to engage thecuffs. The device 100 can therefore be used in the same femoral arteryaccess puncture without disturbing the existing tissue tract and causingundue discomfort to the patient.

When both the elongate bodies 106 and 106′ and the suture 102 passthrough the lumen wall W and into the lumen 107, the elongate bodies 106and 106′ engage with the foot 114. The penetrator tip 108 and anteriorpenetrator tip 108′ of the elongate bodies 106 and 106′ engage withcuffs 110 and 110′ of the foot 114. The cuffs 110 and 110′ include alink 112 that connects the cuffs 110 and 110′ to one another. It shouldbe noted that the cuffs 110 and 110′ facilitate connection of thepenetrator tip 108 with the anterior penetrator tip 108′ such that thepenetrator tip 108 and the anterior penetrator tip 108′ are coupled toone another via the link 112.

FIGS. 16A and 16B show the suture bight in the pre-deployed state (FIG.16A) and the deployed state (FIG. 16B). The suture 102 is arranged toprovide the pre-tied knot 104 that automatically travels down from theshaft of the device where it is stored prior to delivery to the tissuewall. The loop 104 of suture 102 serves to pull the knot 104 down therail portion 140 of the suture during deployment. It should be notedthat it would-be desirable to be able to distinguish the ends 140 and150 of the suture 102 during deployment so that the correct end ispulled by the operator to advance the knot. Should the non-rail end bepulled, the knot may be prematurely tightened before it is advance toits deployed position at the wall of the vessel.

The ends of the suture may be distinguished from each other by changingthe color of one end (e.g. with dye), providing an attachment on one end(e.g. shrink wrap tubing, a bead, etc.) or with the suture itself (e.g.tying a knot in one end).

FIG. 15C shows the penetrator tips fully deployed into and engaged withthe cuffs 110. FIG. 15D shows the penetrators being retracted after thetips have engaged the cuffs 110. On the anterior side 122, thepenetrator 106′ is pulling the anterior cuff 110 distally. On theposterior side 124, the penetrator tip 108 has been disengaged from thepenetrator 106, via a mechanism described below. As shown in FIG. 15D,the link 112 is now coupled to one end of the suture via posterior cuff110. Suture 102 is also shown exiting the posterior penetrator shank viaan opening in the side of the penetrator shank.

Referring to FIG. 15E, after deployment of the foot 114, the suture 102moves as indicated by directional arrows X.sub.1. As the suture 102moves, a suture loop 103 also moves in a direction indicated bydirectional arrow X.sub.2 towards the foot 114 and the incision (notshown). The suture 102 moves through the foot 114 and through an openingdistal to the foot 114 that defines a suture-bearing surface 111. Thesuture-bearing surface 111 is disposed at a distal end of the suturingdevice 100 separate from the foot 114, in this embodiment. The suturebearing surface 111 bears forces placed on the suture 102 duringsuturing. As such, the suture-bearing surface 111 minimizes forcesplaced on an incision during incision tensioning, thereby minimizing thepossibility of damaging tissue immediately surrounding the incision. Inthis embodiment, the suture bearing 111 is a slot disposed at a distalend of the suturing device 100, which includes a passage for the suture102 during incision suturing as shown with reference to the Figure.

As the suture loop 103 and the suture 102 move, the pre-tied suture knot104 also moves in the same direction as the suture loop 103 towards thefoot 114 and the incision. The suture loop 103 continues to move thepre-tied suture knot 104 towards the incision until the suture 102 andthe pre-tied suture knot 104 suture the incision formed in the arterialwall. It should be noted that a suture trimmer might be used to assistthe delivery of the knot 104 to an arteriotomy. The suture trimmer maybe any device suitable for pushing the knot towards the arteriotomy andtrimming suture immediately adjacent the knot 104 once the knot istightened.

Now making reference to FIG. 15F, the suturing device 100 delivers thepre-tied suture knot 104 to the incision and the foot 114 is returned toits non-deployed position. The penetrators (not shown) have beenretracted, the link has been fully retracted through the knot, and theknot has been advanced to the vicinity of the arterial wall. When thebody of the device is removed, a stitch will remain in place across theincision in the artery. It should be noted that embodiments of thedevice described herein place a stitch of suture in a longitudinalorientation with respect to the vessel so as to minimize transversevessel constriction and also to take advantage of the transverseorientation of the fibers of the vessel tissue.

FIGS. 16A and 16B show the suture bight in the pre-deployed state (FIG.16A) and the deployed state (FIG. 16B). The suture 102 is arranged toprovide the pre-tied knot 104 that automatically travels down from theshaft of the device where it is stored prior to delivery to the tissuewall. The loop 104 of suture 102 serves to pull the knot 104 down therail portion 140 of the suture during deployment. It should be notedthat it would be desirable to distinguish the ends 140 and 150 of thesuture 102 during deployment so that the correct end is pulled by theoperator to advance the knot. Should the non-rail end be pulled, theknot may be prematurely tightened before it is advanced to its deployedposition at the wall of the vessel.

The ends may be distinguished from each other by changing the color ofone end (e.g. with dye), providing an attachment on one end (e.g. shrinkwrap tubing, a bead, etc.) or with the suture itself (e.g. tying a knotin on end).

FIG. 17A shows an enlarged detail of the posterior portion of the footof one embodiment of suturing device 300. In an accordance with anembodiment of the present invention, the elongate body 306 may be anytype of structure capable of penetrating the wall of a lumen, such as anartery, a blood vessel, or the like. In addition to the penetrationcapability, the elongate body 306 may be a hollow tube capable ofholding suture. Examples of such structures may include a hypodermicneedle or the like.

The suturing device 300 stores the elongate body 306 within its shaft(not shown). As previously described with reference to FIGS. 2A through2C, a user deploys a handle (not shown) of the suturing device 300thereby deploying the elongate body 306 and the penetrator tip 308.During deployment, the elongate body 306 and the penetrator tip 308penetrate the lumen wall W immediately surrounding the incision 305 andenter the lumen 307 of a patient, as shown with reference the followingFIG. 17B.

Once the penetrator tip 308 engages with the cuff 310, the elongate body306 and the penetrator tip 308, along with the cuff 310, proceed throughthe foot 314 and into the lumen 307. As may be seen with reference toFIG. 17B, the cuff 310 is pushed through the foot 314, such that thecuff 310 is pushed out of a pocket 316 and through the foot 314 into thelumen 307. Once the cuff 310 and the elongate body 306 enter the lumen307, the penetrator tip 308 detaches from the elongate body 306 via apush mandrel 315 as shown with reference to FIG. 17C.

FIG. 17C illustrates the detachment of the pentrator tip 308 from theelongate body 306 in accordance with one embodiment of the presentinvention. Upon engagement of the penetrator tip 308 with the cuff 310,the push mandrel 315 is further advanced such that it contacts aproximal surface 308b of the penetrator tip 308, and further still untilthe penetrator tip 308 detaches from the elongate body 306. Upondetachment of the penetrator tip 308 from the elongate body 306, thepush mandrel 315 and the elongate body 306 retract from the foot 314, asshown with reference to FIG. 17D.

As shown in FIG. 17D, after the penetrator tip 308 detaches from theelongate body 306, the elongate body 306 retracts from the penetratortip 308 and cuff 310. Meanwhile, on the anterior side of the device (notshown in FIG. 17D), the elongate body 306′ also includes the needle tip308′ which engages with the cuff 310′ as previously described withreference to FIG. 15C. The needle tip 308′ does not disengage from theelongate body 306′ upon engagement with the cuff 310′. Therefore, duringretraction of the elongate body 306′ from within the lumen 307, theneedle tip 308′ also retracts from the lumen 307 through the penetration309′. As the needle tip 308′ retracts through the penetration 309′, theelongate body 306′ also retracts the cuff 310′. As previously described,the cuff 3 10′ couples with the cuff 3 10 via the link 312. Duringretraction of the cuff 310′ through the penetration 309′, the cuff 310and the suture 302 also retract through the penetration 309′, therebydrawing the suture 302 through the penetration 309′. It should be notedthat the foot 314 may provide suture bearing surface for the suture 302during operation of the suturing device 300, as shown with reference toFIG. 18A.

FIG. 18A shows an embodiment of the present invention illustrating thepassage of the suture 302 through the lumen 307 and the passageways 309and 309′. As may be seen with reference to the Figure, the cuff pockets316 of the foot 314 provide a suture-bearing surface for the suture 302as the suture 302 is drawn through the passageways. The suture bearingsurfaces of the foot 314 minimize the possibility of the suture 302damaging tissue surrounding the incision 305.

In another embodiment shown in FIG. 18B, the suturing device 300 alsoprovides a suture bearing surface for the suture 302. During retractionof the elongate bodies 306 and 306′ from the lumen 307, the suture 302retracts through the foot suture bearing surfaces 314 a and thesuture-bearing surface 311 formed distally of the foot. The distalsuture bearing surface 311 and the foot suture bearing surfaces 314 aguide the suture 302 in order to minimize the possibility of the suture302 damaging the patient during retraction of the elongate bodies 306and 306′ from the lumen 307. In this embodiment, suture-bearing surface311 is a slot defined in the body of the device distal of the foot. Theslot includes a passage for the link and suture, and an edge 311 a. Itis contemplated that the edge 311 a may contact the edge of the incisionin the artery and become caught on the adventitia of the blood vessel.Various devices may be provided, such as flaps, o-rings, etc., thatprovide a smoother transition over the slot and edge 311 a as the deviceis inserted through the incision.

FIGS. 19A and 19B illustrate an alternative embodiment of the presentinvention for releasing the cuff 310 from the foot 314. In thisembodiment, the foot 314 includes link passageway 313 through which thelink 312 passes. After the elongate body 306 engages the penetrator tip308 with the cuff 310, the elongate body 306, during retraction from thefoot 314, removes the cuff 310 and the penetrator tip 308 from the foot314. The force holding the penetrator tip 308 on the elongate body 306overcomes the force holding the cuff 310 in the cuff pocket 316. Oncethe cuff 310 clears the foot 314 and attains the orientation shown withreference to FIG. 19B, the previously described push mandrel (not shown)detaches the penetrator tip 308 from the elongate body 306. Upondetachment of the penetrator tip 308 from the elongate body 306, thelink 312, along with the cuff 310 and the penetrator tip 308, retractsthrough the passageway 313 via the link 312 and the elongate body 306′.In an alternate embodiment, the cuff 310 and pentrator tip 308 maybepulled off the elongated body 306 by tension in the link 312.

In yet another alternate embodiment shown in FIGS. 20A through 20C, thecuff 310 and penetrator tip 308 may be detached from the elongate body306 before being removed from the cuff pocket 316. In this embodiment,after the elongate body 306 and the penetrator tip 308 engage with thecuff 310, the push mandrel 315 detaches the penetrator tip 308 from theelongate body 306, leaving it in the cuff pocket 316 to be removed bytension in the link 312, as shown in FIG. 20C.

It should be noted that other methods might be used to detach thepenetrator tip 308 from the elongate body 306. These methods include,but are not limited to, detachment through friction or tension. Makingreference to FIG. 20B, in an embodiment where friction between the cuffpocket 316 and the cuff causes detachment of the penetrator tip 308 fromthe elongate body 306, a surface 308 c of the penetrator tip 308frictionally engages with a cuff surface 316 a of the cuff pocket 316.During retraction of the elongate body 306 from the foot 314, thefrictional engagement between the cuff surface 316 a and the penetratortip surface 308 c causes detachment of the penetrator tip 308 from theelongate body 306. In an embodiment where link tension causes detachmentof the penetrator tip 308 from the elongate body 306, the link 312 istensioned such that the link 312 is taut between the cuffs 310 and 310′.As such, the tension of the link 312 prevents movement of the cuff 310out of the foot 314 along with the elongate body 306 during retractionof the elongate body 306 from the foot 314, thereby causing detachmentof the penetrator tip 308 from the cuff 310.

After detachment, during retraction of the elongate body 306 and theelongate body 306′ (not shown), the link 312 may draw the cuff 310 andthe penetrator tip 308 from the cuff pocket 316. As discussed earlier,the cuff 310′ engages with the elongate body 306′ and pulls the cuff 310via the link 312 as the elongate body 306′ retracts from the lumen 307.As such, retracting the link 312 pulls on the cuff 310, thereby pullingthe cuff 310 from the cuff pocket 316 and through the lumen 307 alongwith the suture 302, as shown with respect to FIG. 20C.

FIG. 21 shows the pre-tied suture knot 304 disposed about a periphery ofa knot tube 301. In this embodiment, the knot tube 301 includes a hollowcenter 301 a configured to allow passage of an elongate body (not shown)as the suturing device 300 sutures the incision. However, it should benoted that in an alternative embodiment of the present invention, theelongate body (not shown) might also store the suture 302. In thealternative embodiment, the suture 302 and the pre-tied suture knot 304are disposed about a periphery of the elongate body where the pre-tiedsuture knot 304 may reside within a pocket (not shown) of the elongatebody.

Embodiments of the suturing device of the invention may also includeadditional configurations for a foot, as shown with reference to FIGS.22A through 22C. In this embodiment, the suturing device 300 includes afoot 319 having cuff pockets 319 a and 319 b. The configuration of thecuff pockets 319 a and 319 b allow the foot 319 to hold the cuffs 310and 310′ during use of the suturing device 300. The foot pivots from afirst orientation shown with reference to FIG. 22A to a secondorientation shown with reference to FIG. 22B via a hinge 320 as shown inFIG. 22C.

FIG. 22C shows the hinge 320, which allows rotation of the foot 319 in adirection indicated by directional arrow Y. The hinge 320 may be anydevice capable of rotatably coupling the foot 319 to the suturing device300, such as pin assembly or the like. In addition to the hinge 320, thefoot 319 includes a connector 322 that couples the cuffs 310 and 310′with one another. The connector 322 also includes a flexible portion 322c (shown with respect to FIG. 22C) that allows flexing of the connector322 as the connector 322 resides within passage 317 of the foot 314. Theconnector also includes ends 322 a and 322 b that facilitate connectionwith the penetrator tip 308 and the needle tip 308′ of the elongatebodies 306′ and 306.

In an embodiment of the present invention where the suturing device 300employs the foot 319, during use of the suturing device 300, uponinsertion of the suturing device 300 within the lumen 307, a userdeploys the foot 319 as shown with reference to FIG. 22A. Upondeployment of the foot 319, the user deploys the elongate body 306 (notshown) that engages with the cuff 310 (not shown) as previouslydescribed. Once the penetrator tip 308 detaches from the elongate body306 via the push mandrel 315, or other means previously described, theuser rotates the foot 319 into the orientation shown with reference toFIG. 22B. Upon orientation of the foot 319 as shown with respect to FIG.22B, the user deploys the elongate body 306′ (not shown) which engageswith the cuff 310′ (not shown). After the elongate body 306′ engageswith the cuff 310′, the user retracts the elongate body 306′ along withthe cuffs 310 and 310′ and the suture 302 to suture an incision aspreviously described.

Another embodiment of the suturing device 300 includes feet 324 and 328as shown with reference to FIG. 23A. FIG. 23A illustrates an embodimentof the present invention in which the suturing device 300 includes thefeet 324 and 328. As may be seen with reference to FIG. 23B, the foot324 is hollow such that the foot 328 fits within the foot 324 duringboth insertion and retraction of the suturing device 300 within thelumen 307. The feet 324 and 328 also include cuff pockets 324 a and 328a and cam surfaces 324 b and 328 b. The configuration of the cuffpockets 324 a and 328 a allow placement of the cuffs 310 and 310′ withinthe feet 324 and 328 during use of the suturing device 300; allowingengagement of the elongate bodies 306 and 306′ during suturing. The camsurfaces 324 a and 328 a contact cam surfaces 326 a in order to deploythe feet 324 and 328. Once the feet 324 and 328 deploy, the suturingdevice 300 attains the configuration shown with reference to FIG. 23C.

During use of a suturing device implementing the feet 324 and 328, auser inserts the suturing device into an incision as the foot 328resides within the foot 324. Upon insertion of the suturing devicewithin the incision, the user deploys the feet 324 and 328 by moving thefeet 324 and 328 towards the cam surfaces 326 a, in order to deploy thefeet 324 and 328, as previously described. After deployment of the feet324 and 328 within a lumen, the user deploys the elongate bodies 306 and306′ whereby the penetrator tip 308 and needle tip 308′ engage with thecuffs 310 and 310′ residing within the cuff pockets 324 a and 328 a.Upon engagement with the cuffs 310 and 310′ the user retracts theelongate bodies 306 and 306′ and sutures the incision.

In addition to the alternative configurations for the foot of thesuturing device 300, the suturing device 300 may also includealternative cuff configurations that allow engagement of the elongatebodies 306 and 306′ with the link 312. An example of such an alternativeconfiguration is shown with respect to FIG. 24A. FIG. 24A illustrates aperspective view of an alternative embodiment of the penetrator tip 330.In this embodiment, a penetrator tip 330 includes mating surfaces 330 awhich engage with the previously described cuff tabs 310 a of the cuff310 when the penetrator tip 330 engages with the cuff 310, as shown withreference to FIG. 24B. As such, a user detaches the elongate body 306from the penetrator tip 330 with the push mandrel 315 after engagementof the penetrator tip windows 330 a with the cuff tabs 310, as discussedwith reference to the penetrator tip 308 and the cuff 310. The matingsurfaces 330 a may be cut-outs, such as windows, formed within thepenetrator tip 330. The elongate bodies 306 and 306′ may also engagewith the link 312.

FIG. 25A shows an alternative method of coupling the elongate bodies 306and 306′ with the link 312. In this embodiment, the elongate body 306′includes a loop 332 (shown in FIG. 25B) which engages with the link 312as the elongate body 306′ enters the foot 314. In this embodiment, thelink 312 is constructed of a resilient material capable of flexing inresponse to the loop 332 contacting the link 312, such as polypropyleneor any other material having spring-like characteristics. The elongatebody 306′ moves in a downward direction as indicated by directionalarrow A until the loop 332 comes into contact with an end 312 a of thelink 312. When the loop 332 contacts the end 312 a, the loop 332 movesthe end 312 a in a direction F.sub.1 indicated by directional arrowF.sub.1. The catch 332 continues to move the end 312 a of the link 312in the direction F.sub.1 until the loop 332 contacts the end 312 a, asshown with reference to FIG. 25B.

Referring to FIGS. 25A-C, the link 312 is constructed of a materialhaving spring like properties. Therefore, when the loop 332 a comes intocontact with the end 312 a, the resilient properties of the link 312move the end 312 a in a direction F.sub.2, as indicated by directionalarrow F.sub.2 in FIG. 25A. The end 312 a moves in the direction F.sub.2such that the end 312 a moves into the loop 332 a, as shown withreference to FIG. 25B. Once the end 312 a moves into the loop 332 a, auser retracts the loop 332 along with the end 312 a and the link 312 ina direction B as indicated by directional arrow B of FIG. 25C. As theloop 332 a and the catch 332 move in the direction B, the loop 332 aclamps the link 312 against a surface 306′a of the elongate body 306′.Thus, during retraction of the suturing device 300 from the foot 314,the link 312 remains engaged with the elongate body 306′, as shown withreference to FIG. 25C. As the elongate body 306′ and the catch 332retract from the foot 314, the catch 332 pulls the link 312 through thefoot 314, also as shown with reference to FIG. 25C. While the catch 332pulls the link 312, the cuff 310 (not shown) and the suture 302 (notshown) move through the foot 314 in order to enable suturing of anincision.

In another embodiment, the suturing device 300 may also employ a clipand ring assembly 338 which couples the elongate bodies 306 and 306′with the link 312, as shown with reference to FIG. 26A. FIG. 26Aillustrates a schematic view of the clip and ring assembly 338 forcoupling the elongate bodies 306 and 306′ with the link 312 inaccordance with an embodiment of the present invention. The elongatebodies 306 and 306′ include a clip 336 in place of the penetrator tip308 and the needle tip 308′ where the clip 336 has a configuration asshown with reference to the Figure. The clips 336 include flexible arms336 a and a passageway 336 b.

The clip and ring assembly 338 also includes a ring 334 that engageswith the clip 336. The link 312 couples with the ring 334 using anysuitable technique, such as tying or the like. The ring 334 has acircular configuration as shown with respect to FIG. 26B such that asthe elongate bodies 306 and 306′ engage with the foot 314, the clip 336couples with the ring 334. As the clips 336 engage with the ring 334,the flexible arms 336 a flex in a direction indicated by directionalarrows Y and Z thereby increasing a width W.sub.i of the passageway 336b in order to allow passage of the ring 334 through the clip 336 asshown with regards to FIG. 28C.

Referring to FIG. 26D, there is shown a top view of the foot 314 wherethe foot 314 includes cuff pockets 314 b-1 and 314 b-2. The cuff pocket314 b-1 holds the ring 334 prior to engagement with the clip 336. Thecuff pocket 314 b-2 is configured such that as the elongate bodies 306and 306′ enter the foot 314, the clips 336 enter the cuff pocket 314 b-2and engage with the ring 334 as shown with reference to the Figure. Oncethe clip 336 engages with the ring 334, the clip 336 coupled with theelongate body 306 detaches from the clip 336 while the elongate body306′ remains engaged with the clip 336. During retraction of theelongate bodies 306 and 306′ from the foot 314, the elongate body 306′pulls the link 312 and the suture 302 through the foot 314 in order tosuture an incision.

FIG. 27 shows an embodiment of a cuff 410 and link 412 assembly thatmaybe provide with the various embodiments of the present invention.Cuff 411 has a penetrator tip receiving end 434 and a tapered end 432.Link 412 has two ends 442 (only one shown in FIG. 27). An example of apreferred link material is expanded Polytetrafluoroethylene (ePTFE).PTFE is commonly referred to as Teflon. ePTFE is particularly suited foruse as the link material in the vessel closure devices described hereinbecause of its low friction, high strength properties.

To assemble the link and cuff assembly, a length of link material isfirst threaded through the cuff. The end of the link material extendingfrom the penetrator tip receiving end 434 of the cuff 410 is then heatedso that it expands. The link is then pull through the cuff 410 such thatthe expanded end portion 442 is seated in the interior tapered end 432of the cuff 410.

The present invention offers surgeons an automated method for deliveringa pre-tied knot to an incision formed in a lumen. The present inventionminimizes the problems associated with a surgeon manually delivering aknot to an incision site. Thus, the present invention reduces the timerequired to accurately and precisely place a suture knot in closeproximity to an incision formed in a lumen, thereby decreasing both theoverall time a patient spends in surgery and the costs associated withspending time in surgery.

While illustrative embodiments of the invention are disclosed herein, itwill be appreciated that numerous modifications and other embodimentsmay be devised by those skilled in the art. For example, the variousfeatures of each embodiment may be altered or combined to obtain thedesired device or method characteristics. Therefore, it will beunderstood that the appended claims are intended to cover all suchmodifications and embodiments that come within the spirit and scope ofthe present invention.

1. A method for suturing a puncture in a blood vessel wall using asuturing device, the method comprising: providing a suture having afirst end and a bight spaced from said first end, the bight pre-arrangedon the device; advancing said first end of said suture through the bloodvessel wall; advancing said first end of said suture through said bight;and tensioning said suture across said puncture formed in said bloodvessel wall.
 2. The method of claim 1, further comprising providing afirst needle with a distal tip, and wherein advancing said first end ofsaid suture through said bight includes pulling said first end of saidsuture with said distal tip of said first needle.
 3. The method of claim1, further comprising: providing a shaft, said first needle advanceablealong said shaft, said bight being releasably attached to said shaft;and advancing said shaft through a tissue tract of a patient body. 4.The method of claim 3, wherein providing a suture having a first end anda bight spaced from the first end, the bight pre-arranged on the device,further including the bight being pre-arranged about the first needle.5. A method for suturing a puncture in a blood vessel wall using asuturing device, the method comprising: inserting at least a portion ofa suture through a tissue tract of a patient body and through the bloodvessel wall; advancing a first end of the suture through a bight of thesuture, the bight being pre-arranged on the device; and tensioning thefirst end of the suture and a second end of the suture adjacent thebight to form a knot affixing a loop of suture across the puncture. 6.The method of claim 5, further comprising: providing a shaft, and firstand second needles advanceable along said shaft, said bight beingreleasably attached to said shaft; and advancing said shaft through atissue tract of a patient body.
 7. The method of claim 6, whereinadvancing the first end of the suture through the bight includes pullingthe first end of the suture with the first needle.